FDA Adverse Event
Injury
Summary report: N
11.0MM TI HELICAL BLADE 95MM
MDR report key: 2062603
·
Received April 8, 2011
Report
- Report Number
- 3003506883-2011-00012
- Event Type
- Injury
- Date Received
- April 8, 2011
- Date of Event
- September 15, 2010
- Report Date
- March 29, 2011
- Manufacturer
- SYNTHES ELMIRA
- Product Code
- HSB
- PMA / PMN Number
- K011857
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVAL PROCESS.
Description of Event or Problem · 1
PT IMPLANTED WITH 11MM CANNULATED TROCHANTERIC FIXATION NAIL FOR A LEFT SUBTROCHANTERIC FEMUR FRACTURE ON (B)(6) 2010. F/U X-RAYS 90 DAYS POST OP SHOWED THE NAIL TO BE BROKEN AT THE HELICAL BLADE/NAIL JUNCTION. NAIL WAS REMOVED ON (B)(6) 2010 AND PT REVISED TO ANOTHER INTRAMEDULLARY DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 11.0MM TI HELICAL BLADE 95MM | HELICAL BLADE | HSB | SYNTHES ELMIRA | NA | 6381800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention | NAIL |